After the death of a preterm infant, the FDA warns hospitals against using probiotics to treat premature babies
After the death of a preterm baby who was given a probiotic in a hospital, the US Food and Drug Administration is warning hospitals about using probiotics in infants born prematurely, CNN reported.
In a warning letter on Friday, the federal agency warned health care providers that bacteria and fungus found in probiotics might put premature newborns at risk of "invasive, potentially fatal" infections. The letter mentions an infant who died after being given the probiotic Evivo with MCT Oil.
The infantis subspecies of the bacterium Bifidobacterium longum present in the product is produced by Infinant Health for use in hospital settings.
“Genetic sequencing data show that the bacteria that caused this infant’s sepsis were genetically identical to the bacteria found in this probiotic,” the FDA said in a letter.
Probiotics, which contain live bacteria or other microorganisms that provide health benefits, are popular in the United States in the form of dietary supplements. For this reason, it is not subject to the FDA approval process.
According to the American Academy of Pediatrics, about 10% of preterm infants receive probiotics while in neonatal ICUs, a number that’s steadily increasing across the country.
The group’s most recent guidelines also don’t recommend the supplements for preterm infants.
“Given the lack of FDA-regulated pharmaceutical-grade products in the United States, conflicting data on safety and efficacy, and potential for harm in a highly vulnerable population, current evidence does not support the routine, universal administration of probiotics to preterm infants, particularly those with a birth weight of
